I.S. EN 62570:2015
Current
The latest, up-to-date edition.
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
Hardcopy , PDF
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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FOREWORD
1 Scope
2 Referenced Documents
3 Terminology
4 Significance and Use
5 Requirements for assessment of potential hazards
caused by interactions of an item and the MR Environment
6 Methods of Marking
7 Information Included in MR Marking
8 Keywords
APPENDIX X1 - RATIONALE
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
Pertains to the practice of marking of items that might be used in the magnetic resonance (MR) environment.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 62570:2015 | Identical |
| IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| EN 60601-2-33:2010/A12:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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